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EC number: 938-868-6 | CAS number: -
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- from 2010-11-10 to 2010-11-24
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: well documented GLP Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: SOP/T/21: „Acute dermal toxicity study”
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Slovak National Accreditation Service (No. G-024)
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- disodium 2-[7-(carboxylatomethyl)-4,8-dioxo-1,3-dioxa-6-aza-2-cupracyclooctan-5-yl]acetate
- EC Number:
- 938-868-6
- Cas Number:
- 666828-79-1
- Molecular formula:
- not applicable
- IUPAC Name:
- disodium 2-[7-(carboxylatomethyl)-4,8-dioxo-1,3-dioxa-6-aza-2-cupracyclooctan-5-yl]acetate
- Reference substance name:
- Copper chelate of sodium salt N-[1,2 dicarboxyethyl] D,L aspartic acid
- IUPAC Name:
- Copper chelate of sodium salt N-[1,2 dicarboxyethyl] D,L aspartic acid
- Reference substance name:
- Cu (II) IDHA
- IUPAC Name:
- Cu (II) IDHA
- Test material form:
- other: powdered
- Details on test material:
- - Name of test material (as cited in study report): Cu (II) IDHA
- Substance type: chelate
- Physical state: solid (odourless, blue microgranules)
- Analytical purity: the test item contains 9.82% of copper
- Lot/batch No.: 1/10, date of production: April, 2010
- Expiration date of the lot/batch: April, 2013
- Storage condition of test material: in tightly closed packed at temperature from -10°C to +30°C
Constituent 1
Constituent 2
Constituent 3
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: conventional husbandry of laboratory animals of Institute of Occupational Medicine, Łódź
- Age at study initiation: 10 weeks old
- Weight at study initiation: 295.8 g (males) and 218.2 g (females)
- Fasting period before study: none
- Housing: in cages with dimensions (length x width x height): 58 x 37 x 21 cm; with plastic bottom and wired lid. After application of the test item each animal was kept individually in cage. After removal of test item from animals’ skin during the following days of experiment, the rats were kept five per cage, each separately. UV-sterilized wooden shavings were used as a bedding.
- Diet (e.g. ad libitum): ad libitum standard granulated "Murigran" fodder produced by Wytwórnia Koncentratów i Mieszanek Paszowych AGROPOL, Motycz
- Water (e.g. ad libitum): ad libitum, tap water
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 - 23 °C;
- Humidity (%): 47 – 63 %
- Air changes (per hr): about 16 times/hour
- Photoperiod (hrs dark / hrs light): 12 / 12
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: ca. 41 cm² (males) ca. 31 cm² (females)
- Type of wrap if used: gauze patches were covered with PCV foil and elastic bandage was used to make circular protecting band
REMOVAL OF TEST SUBSTANCE
- Washing (if done): water
- Time after start of exposure: 24 hours after application of chemical and immediately after removal of the gauze patch
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bw
- Constant volume or concentration used:no
- For solids, paste formed: no (The test item was applied to gauze patches, moistened with few drops of water and then laid on prepared skin.)
VEHICLE
- Amount(s) applied (volume or weight with unit): a few drops of water were applied to the powdered amount of chemical on the gauze patch - Duration of exposure:
- 24 h
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: General and detailed clinical observations were performed in all animals daily during the entire experiment. Body weight of animals was individually determined for each animal: on day 0 (directly before administration of test item) and on 7th and 14th day.
- Necropsy of survivors performed: yes (All animals were sacrificed after 14-day observation period, dissected and subjected to detailed gross necropsy. )
- Other examinations performed: clinical signs, body weight, gross necropsy
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- no mortality occurred
- Clinical signs:
- other: no general signs of toxicity were stated in the animals. Changes in form of erythema, dryness of epidermis, desquamation of epidermis and scabs were stated on the skin in the site of test item application. Dryness of epidermis and scabs were stated in fiv
- Gross pathology:
- No pathological changes were stated in animals at gross necropsy.
- Other findings:
- no other findings reported
Any other information on results incl. tables
Following single application of test item no general signs of toxicity were stated in animals. Changes in form of erythema, dryness of epidermis, desquamation of epidermis and scabs were stated on skin in the site of test item application. Dryness of epidermis and scabs were stated in five males whereas desquamation of epidermis – in one male. Erythema and scabs were stated in four females, dryness of epidermis – in five females, desquamation of epidermis – in two females. These were transient changes except dryness of epidermis in three females which was observed till the end of experiment. All animals survived period of experiment. Slight body weight loss was stated in one female No 2 (6g) and three males No 1 (3g), No 4 (6g) and No 5 (8g) during 1st week of experiment. Body weight gains were stated in all animals after 14-day period of experiment. No pathological changes were stated in animals at gross necropsy.
Table 1: Summary of findings
Cu (II) IDHA: acute dermal toxicity study on rats | ||
Administered dose of test item(mg/kg b.w.) | 2000 | |
Sex | males | females |
Mortality of animals | 0/5 | 0/5 |
Clinical signs | no general clinical signs; | no general clinical signs; |
on treated skin: dryness of epidermis and scabs (in 5 males) | on treated skin: erythema and scabs (in 4 females) | |
on treated skin: desquamation of epidermis (in 1 male) | on treated skin: dryness of epidermis (in 5 females) | |
on treated skin: desquamation of epidermis (in 2 females) |
Clinical signs
Following single application of test item no general signs of toxicity were stated in animals. Changes in form of dryness of epidermis from 2nd – 10th to 5th – 13th day and scabs from 2nd to 5th – 9th day after administration were stated in five males on skin in the site of test item application. Furthermore, desquamation of epidermis on 2nd day after administration was stated in one male (No 1). Changes in form of erythema on 2nd day and scabs from 2nd to 9th – 14th day after administration were stated in four females (No 1, No 2, No 3 and No 5). Changes in form of dryness of epidermis from 2nd – 3rd to 4th – 5th day after administration were stated in five females. Furthermore, dryness of epidermis formed in place of scabs was observed in four females (No 1, No 2, No 3 and No 5) from 8th – 9th to 11th – 14th day after administration. Desquamation of epidermis on 2nd day after administration was stated in two females (No 1 and No 4). All animals survived period of experiment. The overall list of results of clinical observations is presented in Table 2.
Table 2 - Clinical signs - overall list | ||||||||
Cu (II) IDHA: acute dermal toxicity study on rats | ||||||||
Dose (mg/kg b.w.) | Sex | Day after administration | Number of alive animals | Rat No | ||||
1 | 2 | 3 | 4 | 5 | ||||
2000 | males | 0 | 5 | NC | NC | NC | NC | NC |
1 | 5 | NC | NC | NC | NC | NC | ||
2 | 5 | SIGNS | SIGNS | SIGNS | SIGNS | SIGNS | ||
3 | 5 | SIGNS | SIGNS | SIGNS | SIGNS | SIGNS | ||
4 | 5 | SIGNS | SIGNS | SIGNS | SIGNS | SIGNS | ||
5 | 5 | SIGNS | SIGNS | SIGNS | SIGNS | SIGNS | ||
6 | 5 | NC | SIGNS | SIGNS | SIGNS | SIGNS | ||
7 | 5 | NC | SIGNS | SIGNS | SIGNS | SIGNS | ||
8 | 5 | NC | SIGNS | SIGNS | SIGNS | SIGNS | ||
9 | 5 | NC | SIGNS | SIGNS | NC | SIGNS | ||
10 | 5 | NC | SIGNS | SIGNS | NC | SIGNS | ||
11 | 5 | NC | SIGNS | SIGNS | NC | SIGNS | ||
12 | 5 | NC | SIGNS | SIGNS | NC | SIGNS | ||
13 | 5 | NC | NC | SIGNS | NC | SIGNS | ||
14 | 5 | NC | NC | NC | NC | NC | ||
females | 0 | 5 | NC | NC | NC | NC | NC | |
1 | 5 | NC | NC | NC | NC | NC | ||
2 | 5 | SIGNS | SIGNS | SIGNS | SIGNS | SIGNS | ||
3 | 5 | SIGNS | SIGNS | SIGNS | SIGNS | SIGNS | ||
4 | 5 | SIGNS | SIGNS | SIGNS | SIGNS | SIGNS | ||
5 | 5 | SIGNS | SIGNS | SIGNS | SIGNS | SIGNS | ||
6 | 5 | SIGNS | SIGNS | SIGNS | NC | SIGNS | ||
7 | 5 | SIGNS | SIGNS | SIGNS | NC | SIGNS | ||
8 | 5 | SIGNS | SIGNS | SIGNS | NC | SIGNS | ||
9 | 5 | SIGNS | SIGNS | SIGNS | NC | SIGNS | ||
10 | 5 | SIGNS | SIGNS | SIGNS | NC | SIGNS | ||
11 | 5 | SIGNS | SIGNS | SIGNS | NC | SIGNS | ||
12 | 5 | SIGNS | SIGNS | SIGNS | NC | NC | ||
13 | 5 | SIGNS | SIGNS | SIGNS | NC | NC | ||
14 | 5 | SIGNS | SIGNS | SIGNS | NC | NC | ||
NC - no changes | ||||||||
SIGNS - clinical signs |
Body weight of animals
Slight body weight loss was stated in one female No 2 (6g) and three males No 1 (3g), No 4 (6g) and No 5 (8g) during 1st week of experiment. Body weight gains were stated in all animals after 14-day period of experiment.
Table 2- Bodyweight of animals (g)-overall list | ||||||
Cu(II)IDHA:acute dermal toxicity study on rats | ||||||
Dose(mg/kgb.w.) | Sex | Rat No | Day of experiment/Body weight(g) | Body weight gain(g)(0-14) | ||
0 | 7 | 14 | ||||
2000 | males | 1 | 308 | 305 | 310 | 2 |
2 | 292 | 295 | 312 | 20 | ||
3 | 299 | 302 | 322 | 23 | ||
4 | 287 | 281 | 296 | 9 | ||
5 | 293 | 285 | 306 | 13 | ||
females | 1 | 218 | 220 | 237 | 19 | |
2 | 216 | 210 | 230 | 14 | ||
3 | 219 | 220 | 233 | 14 | ||
4 | 223 | 231 | 235 | 12 | ||
5 | 215 | 228 | 232 | 17 |
Gross examination
At necropsy no pathological changes were stated in males and females sacrificed after 14-day experiment period.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- On the ground of the study, one may state that the median dermal lethal dose (LD50) for Cu (II) IDHA is greater than 2000 mg/kg b.w.
- Executive summary:
A study was conducted to test the dermal toxicity potential of Cu (II) IDHA in rats (Kropidlo, A., 2010). Following the single administration of the analysed substance at dose level of 2000 mg/kg bw (semi-occlusive application to the shaved skin for 24 hours) to 5 female and 5 male Wistar rats, no symptoms of general toxicity were observed within the 14 day observation period. No mortality was observed. Changes in form of erythema, dryness of epidermis, desquamation of epidermis and scabs were stated on skin in the site of test item application. Dryness of epidermis and scabs were stated in five males whereas desquamation of epidermis – in one male. Erythema and scabs were stated in four females, dryness of epidermis – in five females, desquamation of epidermis – in two females. These were transient changes except dryness of epidermis in three females which was observed till the end of experiment. Slight body weight loss was stated in one female No 2 (6g) and three males No 1 (3g), No 4 (6g) and No 5 (8g) during 1st week of experiment. Body weight gains were stated in all animals after 14-day period of experiment. No pathological changes were stated in animals at gross necropsy. On the ground of the study, one may state that the median dermal lethal dose (LD50) for Cu (II) IDHA is greater than 2000 mg/kg b.w.
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